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REGISTRATION FORM FOR PATHOGEN, SELECT AGENTS and HUMAN CELLS/TISSUES
Please complete (hard copy or MS Word file) and return to the Office of Research and Sponsored Programs, Box 70565, Fax: 439-6050.
May also be emailed to research@etsu.edu
(ETSU Biosafety Committee Use only)
Reg. NO.: _____________________
Biosafety Level: _______________________
Principal/Responsible Investigator (print): __________________________________
Department: _____________________________
Alternate Contact Person (print): ________________________________ Phone (PI): ______________Phone (Alt. Contact)__________
Email (PI): __________________________________________________ Email (Alt. Contact): ________________________________
Laboratory Location(s): __________________________________________________________________________________________
Project Title:
Date: __________________________
Please check off the Parts being completed:
____ Part A: Pathogenic Microorganisms: Agents capable of causing disease in immune-normal, healthy adults and includes
organisms classified as requiring work at BSL-2 or higher in the latest edition of the CDC/NIH Biosafety in Microbiological and
Biomedical Laboratories (BMBL) 4th Edition.
Registration is required for BL 2 organisms or higher.
____ Part B: Human Blood, Human Cell Lines and Tissues or Other Potentially Infectious Materials (OPIM):
Includes established cell lines of human/primate origin (including those obtained from commercial sources) and OPIM (material with
the potential for transmission of HIV, HBV, HCV, and other bloodborne diseases, including tissue from animals known to be infected
with any of these agents, microbial stocks and cultures, certain body fluids, unfixed human tissue, primary tissue/cell cultures). These
must be handled under BSL-2 conditions as if they were primary cells or tissues.
____ Part C: “Possession, Use and Transfer” of Select Agents, Toxins, High Consequence Livestock or Plant Pathogens. The
use of these agents, toxins or pathogens is regulated by the Select Agent Regulation, 42 CFR 73.0, and the Agricultural Bioterrorism
Protection Act of 2002 . Facility Registration is required and is administered by the Centers for Disease Control, and/or the USDA. If
you anticipate obtaining these materials complete Part C of this form. Additional requirements of the "USA Patriot Act" and the
"Public Health Security, Bioterrorism and Response Act of 2002" must also be satisfied. ANY USE OF SELECT AGENTS MUST
BE APPROVED AND PROCESSED BY THE BIOSAFETY COMMITTEE. Approval of use of select agents will take several
weeks.
____ Part D: Administration to animals of any of the above selections: Administration of any of the above agents to animals
requires approval of the UCAC and may also require that the animals be housed in microisolator or filtered, ventilated cages and
handled under BSL-2 conditions.
____ Part E: Safety Measures: THIS SECTION MUST BE COMPLETED FOR ALL REGISTRATIONS.
____Part F: Affirmation : THIS SECTION MUST BE COMPLETED FOR ALL REGISTRATIONS.
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Part A - Pathogenic Micro-organisms: To be completed by the Principal Investigator for all laboratories handling or storing pathogenic
microorganisms (agents capable of causing disease in immune-normal, healthy adults and includes organisms classified as requiring work
at BSL-2 or higher in the latest edition of either the CDC/NIH publication, Biosafety in Microbiological and Biomedical Laboratories or
the NIH's Guidelines for Research Involving Recombinant DNA Molecules. Complete Part A for each organism used in the lab. Like
organisms can be grouped on a single form.
1.
Name of Organism(s) (genus, species, strain description)
Is organism attenuated?
3. Is drug resistance expressed?
2. Is a toxin produced?
Yes ( )
Yes ( ) No ( )
Work with toxin?
Yes ( )
4. Where is organism stored? Room/location_______________
No ( )
Yes ( )
No ( )
No ( )
Are Biohazard Warning Labels in use?
Yes ( ) No ( )
5. Largest volume used: ____________ liter(s)
6. Is organism inactivated prior to use?
7a. Do you concentrate the organism in your protocol?
Yes ( ) No ( )
Specify Method: __________________
7b. Specify method: _____centrifugation _____precipitation
_____filtration
_____other
8a. Building and room where organism is used?
Yes ( )
9. Does the laboratory work with human blood or blood
products, unfixed human tissue, or human or other primate cells?
8b. Source of Organism:
No (
)
Yes
(
) (if yes, fill out Part B below)
8c. CDC Shipping permit #: ________________________
10. Are cultures, stocks, and items contaminated items decontaminated prior to disposal?
Method: autoclave
chemical disinfectant
No (
)
Yes
(
other (specify):____________________________________________
Brief description of proposed research (please include enough information to describe project’s specific aims):
Part B - Human Cells and Tissues: (includes ATCC established cell lines of human/primate origin or OPIM)
1.
2.
3.
4.
5.
6.
7.
8.
9.
Brief description of proposed research (please include enough information to describe project’s specific aims):
April 2005
No ( )
)
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Part C: Possession, Use or Transfer of "Select Agents, Toxins, High Consequence Livestock/Plant Pathogens". The university is
required to register with the CDC or USDA for possession, use or transfer of any of these agents, toxins or pathogens. These agents are
regulated by Select Agent Regulation, 42 CFR 73.0 and the Agricultural Bioterrorism Protection Act of 2002. If you anticipate obtaining
these materials complete Part C of this form. Additional requirements of the "USA Patriot Act" and the "Public Health Security,
Bioterrorism and Response Act of 2002" must also be satisfied.
Are, or will, any of the following agents, toxins or pathogens be used in your laboratory :  Yes  No.
If "yes", please indicate which by marking the box next to the item with a check () or an “X”.
SELECT AGENTS, TOXINS, HIGH CONSEQUENCE LIVESTOCK/PLANT PATHOGENS
Viruses (HHS and USDA)
Bacteria (HHS and USDA)


Akabane virus
Bacillus anthracis
African swine fever virus
African horse sickness virus
Avian influenza virus (highly pathogenic)
Blue tongue virus (Exotic)
Bovine spongiform encephalopathy agent
Camel pox virus
Classical swine fever virus
Crimean-Congo hemorrhagic fever virus
Eastern Equine Encephalitis virus
Ebola viruses
Foot and mouth disease virus
Goat pox virus
Cercopithecine herpesvirus 1 (Herpes B virus)
Japanese encephalitis virus
Lassa fever virus
Brucella abortus
Brucella melitensis
Brucella suis
Burkholderia mallei (formerlyPseudomona mallei)
Burkholderia pseudomallei
Botulinum neurotoxin producing species Clostridium
Cowdria ruminantium (Heartwater)
Coxiella burnetti
Francisella tularensis
Mycoplasma capricolum/ M.F38/M. mycoides capri
Mycoplasma mycoides mycoides
Rickettsia prowazekii
Rickettsia rickettsii
Yersinia pestis
Lumpy skin disease virus
Malignant catarrhal fever virus (Exotic)
Marburg virus
Coccidioides immitis
Coccidioides posadasii
Menangle virus
Monkeypox virus
Newcastle disease virus (VVND)
Nipah and Hendra Complex viruses
Peste Des Petits Ruminants virus
Rift Valley fever virus
Rinderpest virus
Sheep pox virus
South American Hemorrhagic fever viruses
Junin
Machupo
Sabia
Flexal
Abrin
Botulinum neurotoxins
Conotoxins
Clostridium perfringens epsilon toxin
Diacetoxyscirpenol
Ricin
Saxitoxin
Shigatoxin
Shiga-like ribosome inactivating proteins
Staphylococcal enterotoxins
T-2 toxin
Tetrodotoxin
Guanarito
Swine vesicular disease virus
Tick-borne encephalitis complex (flavi) viruses
Central European Tick-borne encephalitis
Far Eastern tick-borne encephalitis
Russian Spring and Summer encephalitis
Kyasanur Forest disease
Omsk Hemorrhagic Fever
Variola major virus (Smallpox virus)
Variola minor virus (Alastrim)
Venezuelan Equine Encephalitis virus
Vesicular stomatitis virus (Exotic)
Liberobacter africanus
Liberobacter asiaticus
Peronosclerospora philippinensis
Phakopsora pachyrhizi
Plum Pox Potyvirus
Ralstonia solanacearum race 3, biovar 2
Schlerophthora rayssiae var zeae
Synchytrium endobioticum
Xanthomonas oryzae
Xylella fastidiosa (citrus variegated chlorosis strain)
Fungi
Toxins (HHS and USDA)
USDA Plant Pathogens
Genetic Elements, Recombinant Nucleic Acids, and Recombinant Organisms: * If your research
involves rDNA, you must submit a registration form with the IBC. Contact ETSU Biosafety Committee to obtain more
information.
(1) Select agent viral nucleic acids (synthetic or naturally derived, contiguous or fragmented, in host chromosomes or in expression vectors)
that can encode infectious and/or replication competent forms of any of the select agent viruses.
(2) Nucleic acids (synthetic or naturally derived) that encode for the functional form(s) of any of the toxins listed in if the nucleic acids: (i) are
in a vector or host chromosome; (ii) can be expressed in vivo or in vitro; or (iii) are in a vector or host chromosome and can be expressed in
vivo or in vitro.
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


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(3) Viruses, bacteria, fungi, and toxins listed that have been genetically modified.
Part D: Animal Use: Will biohazardous materials be administered to animals?
Yes ( )
If yes, what species: ______________________________________
Is the material an animal pathogen? Yes ( ) No ( )
Is the material a human pathogen?
Yes ( ) No ( )
Will the material or organism be inactivated prior to use in animals? Yes ( )
No ( )
No ( )
Experimental administration route, volume, titer:
Caging: microisolator cages?
Yes ( )
No ( ) Other? ____________________________________________________________
Special procedures needed for containment: _________________________________________________________________
Work in biosafety cabinet? Yes ( ) No ( )
Other? _______________________________________________________________________________________________
Animal Biosafety level requested:
UCAC #:
UCAC Approval Pending? (
UCAC Approval date:
)
(attach detailed procedure if biohazards do not fit conventional Animal Biosafety Level 1 or 2 work practices)
Reference CDC/NIH BMBL Animal Biosafety Levels: http://www.cdc.gov/od/ohs/biosfty/bmbl4/bmbl4toc.htm
Part E: Safety Measures:
Research will be conducted at Biosafety Level _____ (Contact Biosafety Committee if you need assistance in determining the
appropriate classification). Reference CDC/NIH BMBL4 th Edition. Web address:
http://www.cdc.gov/od/ohs/biosfty/bmbl4/bmbl4toc.htm
Engineering controls: available to control significant aerosol generating steps for work requiring BL-2 containment or higher (e.g.,
centrifugation, vortexing, sonication, egg harvesting), check all that apply:
_____
_____
_____
_____
Biological Safety Cabinet (BSC): Class I ______Class II______ Last date of BSC Certification (Mo/Yr) ___________
Centrifuge
Are centrifuge safety cups available and used? Yes ( ) No ( )
Containment suite
Other: ___________________________________________________
Sharps: (e.g., syringes, scalpels, glass) used with BSL-2 and higher organisms must be minimized.
Will (syringes, scalpels, glass) be used? _____ Yes _____No
Has the research protocol been reviewed to minimize the use of sharps where possible? _____ Yes _____No
Are sharps with integrated safety devices available? _____ Yes ______ No.
If yes, please describe device (Type, Model, Brand): _________________________________________________________________
Personal protective equipment: check all that are recommended and available for your work:
_____
_____
_____
_____
Lab coat
Gloves: nitrile ________ non-powdered latex (powdered latex not recommended) ________ vinyl ___________
Safety glasses with side shields
Other: ________________________________________________________________________________________
Disinfectant(s) which will be used for routine cleaning & spills: 1/10 bleach___70% ethanol___ povidone-iodine____ other: ______
Describe the Infectious Waste Handling procedures to be used (note, all laboratory ware and culture media that contacts BL2
organisms or recombinant materials are to be inactivated prior to disposal).
Solids - Disinfection method: autoclave_______ 1/10 bleach______ povidone-iodine_______70% ethanol _____ other: _________
Liquids - Disinfection method: autoclave______ 1/10 bleach_____ povidone-iodine ________ 70% ethanol _____ other:________
April 2005
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Medical Surveillance (check all that apply):
_____
1) No medical surveillance necessary
_____ 2) Employees have been provided Bloodborne Pathogens (BBP) training within the past year. All potentially
exposed employees have received Hepatitis B vaccine or proven immunity. (Basic OSHA BBP compliance adequate
for BL-2 work.)
_____ 3) Additional vaccination/surveillance required for work on this project.
_____ 4) Individuals at increased risk of susceptibility to agent (e.g., preexisting diseases, medications, compromised
immunity, pregnancy or breast feeding) have been referred to appropriate personnel for counseling.
Project Personnel: Principal Investigators, use the following table to list all personnel in your laboratory who handle or may otherwise
be exposed to any of the microorganisms. (attach sheet if necessary).
Name
*
Lab Person’s Initials*
Title
indicates person who initialed this form has been informed of potential hazards and safe work practices)
Part F –AFFIRMATION:
I accept responsibility for the safe conduct of work with this material. I accept responsibility for ensuring that all personnel associated
with this work have received the appropriate training on the hazards and the level of containment required to perform this research safely.
I will report to Biosafety committee any accident or incident that results in a potentially toxic exposure to personnel or any incident
releasing recombinant DNA or other potentially hazardous materials into the environment.
Principal/Responsible Investigator: __________________________________
Signature: ______________________________________________
Date: __________________________
Grant Agency: ___________________________________________
Award #: _______________________
For Committee Use:
Approval: ( ) Yes
( ) Yes, approved with modifications *(see notes below)
( ) No
Signatures:
IBSC Chairman / Representative: ________________________________________________Date _____________________________
Biological Safety Officer: _____________________________________________Date _____________________________
Department Chairperson: ______________________________________________________Date _____________________________
Employee Health Physician (as appropriate):_______________________________________Date ______________________________
Veterinarian: (as appropriate) _______________________________________________________________Date __________________
* Modifications:
IRB approval required ( )
UCAC approval required
(
April 2005
IRB approval: (
)
)
IRB #:______________
Other ( ) Describe:
IRB pending: ( )